ADVIA Centaur aTPOII MCM 11203693

GUDID 00630414608822

aTPOII ADVIA Centaur - MCM 4 x 1 x 1.0 mL

Siemens Healthcare Diagnostics Inc.

Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, calibrator

• Primary Device ID: 00630414608822
• NIH Device Record Key: cb4b7a92-9525-4e3e-b3d7-a33843f70ee0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVIA Centaur aTPOII MCM
• Version Model Number: 11203693
• Catalog Number: 11203693
• Company DUNS: 064608573
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(877)229-3711
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414608822 [Primary]

FDA Product Code

• JJX: Single (specified) analyte controls (assayed and unassayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-08
• Device Publish Date: 2025-11-21

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414608822 - ADVIA Centaur aTPOII MCM: 2026-01-08aTPOII ADVIA Centaur - MCM 4 x 1 x 1.0 mL
• 00630414608822 - ADVIA Centaur aTPOII MCM: 2026-01-08 aTPOII ADVIA Centaur - MCM 4 x 1 x 1.0 mL
• 00630414320298 - Atellica CH Urine Albumin (UAlb): 2025-08-19 Atellica CH Microalbumin (UAlb) Reagent
• 00630414320304 - Atellica CH UAlb CAL: 2025-08-19 Atellica CH Microalbumin (UAlb) Calibrator
• 00630414579108 - ADVIA Centaur ELF Quality Control: 2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - ADVIA Centaur - CLT 3 x 3 x 2.0 mL
• 00630414598901 - Atellica IM Enhanced Liver Fibrosis Quality Control (ELF QC): 2025-08-18 Enhanced Liver Fibrosis (ELF) QC Kit - Atellica IM - CLT 3 x 3 x 2.0 mL
• 00630414632926 - Atellica IM DHEAS2 100T KIT: 2025-03-28 Atellica IM DHEASII 100T KIT
• 00630414632940 - Atellica IM DHEAS2 MCM SET: 2025-03-28 Atellica IM DHEASII MCM SET
• 00630414321486 - Atellica IM DHEAS2 (REF) 500T: 2025-03-28 Atellica IM DHEAS2 (REF) 500T Atellica IM-REF Reagent (REF RGT)